...identification
Performing environmental monitoring including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas
Performing acceptance testing of commercially prepared microbiological culture media...
...FTC)
Dublin Clinical Statistical Analyst
Cork IPT Process Support Specialist (24/7 shi
Carlow Research Assistant
Dublin Aseptic Manufacturing Project Engineer
Mayo Senior Electronic Engineer
Dublin Senior Recruitment Consultant
Dublin Senior R&D Engineer...
...Requirements
University degree in Science or Engineering.
Experience in pharmaceutical product manufacture, preferably biologics and aseptic manufacture.
Good awareness of industry standards and regulations.
Demonstrated competency within multiple areas of...
...Working closely with manufacturing to ensure the CIP/SIP and dirty holds are to the correct times and samples are taken.
Experience in aseptic technique
Experience in Gowning for IOS7/ISO8
Generating and Executing Validation Protocols.
Actively look for Continuous...
...assessment of changes the proposed revision of interventions and desired outcomes.
~ Assist or perform others to perform proper aseptic techniques isolation procedures and infection control measures.
~ Demonstrate ability to assess patients understanding of and compliance...
...microbiology techniques.
Significant level of cross training and demonstrated training ability on multiple microbiological techniques (e.g., aseptic technique, bioburden, endotoxin, growth promotion, environmental monitoring, and microbial identification).
Good understanding of...
...Preferred Experience and Skills:
· Experience in Fill Finish activities – (Vial / Syringe finish, Sterilization, cleaning aseptic manufacturing, etc.)
· Demonstrated ability to independently manage projects/work to schedule/deadlines.
· Statistics experience...
...such as Schedules, User Requirements, Design Documents, IQ/OQ/FAT Protocols for L2 Systems ranging from Standalone Lab Equipment to Aseptic Filling Line.
Attend and Support Qualification and Validation activities.
Support the development of site procedures for the administration...
...Limerick Senior R&D Engineer
Clare Quality - Tech Transfer Specialist
Cork Associate Director Global Patient Safety
Dublin Aseptic Process Lead
Carlow Specialist Operations Engineer
Tipperary Senior Technical Transfer Engineer
Cork Project Process Engineer...
...schedule and to the appropriate compliance and safety standards.
Other responsibilities will be to provide support on the existing Aseptic Syringe Filling Line which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling...
...pharmaceutical manufacturing environment
An understanding of basic pharmaceutical processes such as a solid dose manufacturing process, aseptic manufacturing processes, packaging process, etc.
Experience in risk management tools and techniques
Ability to communicate with...
...an advanced degree is preferred;
- 2+ years in the pharmaceutical or medical device industry is preferred;
- Prior knowledge of aseptic practices in clean room environments is essential;
- Strong knowledge of GMP regulatory guidelines, quality systems, drug product manufacturing...
...company with a large activity scope.
As a Manufacturing QA Compliance Analyst, you will provide real-time shop floor oversight to Aseptic operations, both manufacturing, sampling and testing, partnering with Site colleagues to create an environment of the highest performance...
...a Process Engineer, we require an experienced professional from the pharmaceutical or life sciences sector.
The Process Engineer (Aseptic filling process) is responsible for supporting the site manufacturing team to consistently deliver on specific area Key Performance Indicators...